Micronutrient DeficiencyNCT03764800
The Prevalence of Micronutrient Deficiency in Early School-age Children
An observational study of Micronutrient Deficiency, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiency
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 5 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This cross-sectional descriptive study uses a structured questionnaire to elicit information from parents in Taiwan who are early school-age children aged 4-7 years (<7 years old). Participants are recruited from clinic in Chang Gung Children's medical center, Chang Gung Memorial Hospital. A total of 250 participants who meet the eligibility criteria are enrolled.
Who may be able to join
- 4-7 years old (<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire
Who cannot join
- At the time of the enrollment, there is an acute infection (respiratory, gastrointestinal or urinary tract), and there are organic diseases (heart, lung, brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Micronutrient Deficiency in Early School-age Children and Its Correlation With Eating Behavior, Dietary Habits, Development, Physical Activity, Nutritional Status and Health Status
This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status.
Read the detailed description
A structured questionnaire is used to conduct a cross-sectional descriptive study of 250 early school-age children aged 4-7 years (<7 years old) in Taiwan. Data collection would include: demographics, food preferences, eating behavior, body weight and height, body mass index (BMI), physical activity, records of medical illness, peripheral cell blood count, serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and compared using standard statistical tests. The correlations among eating behavior, dietary habits, development, physical activity, nutritional status, and health status, and micronutrient deficiency are evaluated.
- Conditions
- Micronutrient Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change serum concentrations of Hb (g/dL) may be found in children's serum
Change serum concentrations of Hb (g/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Measured: On the day of enrollment
Change serum concentrations of ferritin (ng/ mL) may be found in children's serum
Change serum concentrations of ferritin (ng/ mL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Measured: On the day of enrollment
Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum
Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Measured: On the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion5 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficiencyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsun-Chin Chao, Chang Gung Memorial Hospital
- Investigators
- Hsun-Chin Chao, A.P., Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764800
- Sponsor's protocol ID
- 201801719A3
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Micronutrient Deficiency in Early School-age Children and Its Correlation With Eating Behavior, Dietary Habits, Development, Physical Activity, Nutritional Status and Health Status
- ClinicalTrials.gov ID
- NCT03764800
- Acronym / sponsor ID
- 201801719A3
- Conditions
- Micronutrient Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 5 Dec 2020 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to assess the prevalence of deficiency in micronutrients in early school-age children and its correlation with picky eating behavior, physical activity, nutritional status, and health status.
Detailed description
A structured questionnaire is used to conduct a cross-sectional descriptive study of 250 early school-age children aged 4-7 years (<7 years old) in Taiwan. Data collection would include: demographics, food preferences, eating behavior, body weight and height, body mass index (BMI), physical activity, records of medical illness, peripheral cell blood count, serum values of ferritin and micronutrients (iron, zinc, copper). Data from children define as picky or non-picky eaters base on parental' questionnaire responses, are analyzed and compared using standard statistical tests. The correlations among eating behavior, dietary habits, development, physical activity, nutritional status, and health status, and micronutrient deficiency are evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This cross-sectional descriptive study uses a structured questionnaire to elicit information from parents in Taiwan who are early school-age children aged 4-7 years (<7 years old). Participants are recruited from clinic in Chang Gung Children's medical center, Chang Gung Memorial Hospital. A total of 250 participants who meet the eligibility criteria are enrolled.
Key inclusion criteria (1 listed)
- 4-7 years old (<7 years old) school-age children, legal representatives willing to sign the consent form and fill in the questionnaire
Key exclusion criteria (1 listed)
- At the time of the enrollment, there is an acute infection (respiratory, gastrointestinal or urinary tract), and there are organic diseases (heart, lung, brain, hepatobiliary, kidney, endocrine metabolic disease or heredity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change serum concentrations of Hb (g/dL) may be found in children's serum
Time frame: On the day of enrollment
Change serum concentrations of Hb (g/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Change serum concentrations of ferritin (ng/ mL) may be found in children's serum
Time frame: On the day of enrollment
Change serum concentrations of ferritin (ng/ mL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children's serum
Time frame: On the day of enrollment
Change serum concentrations of iron (μg/dL), zinc (μg/dL), and copper (μg/dL) may be found in children with picky eating behavior, low quality of development, inadequacy of physical activity, undernutrition, and poor health status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsun-Chin Chao, A.P. study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronutrient Deficiency, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change serum concentrations of Hb (g/dL) may be found in children's serum (time frame: On the day of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.